The following data is part of a premarket notification filed by Portable Therapeutix with the FDA for Portable Therapeutix Squid Active Cold Compression Device And Cold Pack For Otc Use.
| Device ID | K133483 |
| 510k Number | K133483 |
| Device Name: | PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | PORTABLE THERAPEUTIX 2001 HONOR AVE. Ashland, MA 01721 |
| Contact | Sharyn Orton, Ph.d. |
| Correspondent | Sharyn Orton, Ph.d. PORTABLE THERAPEUTIX 2001 HONOR AVE. Ashland, MA 01721 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-13 |
| Decision Date | 2014-03-11 |
| Summary: | summary |